Mesh Positioning System for Laparoscopic Ventral Hernia Repair

ABSTRACT

Novel mesh implant positioning systems for use in laparoscopic body wall defect repairs, such as hernia defects, are disclosed. The systems utilize one or more bar members combined with surgical sutures and needles to position a mesh implant adjacent to a body wall defect without the need for stay sutures. Also disclosed are assemblies of the positioning systems with surgical mesh repair implants, and methods of repairing body wall defects such as hernias with the assemblies.

FIELD OF THE INVENTION

The field of art to which this invention pertains is medical devices andsystems for repairing body wall defects, more particularly medicaldevices and systems for facilitating the implantation of tissue repairimplants in hernia repair procedures.

BACKGROUND OF THE INVENTION

Minimally invasive laparoscopic hernia repair procedures are well knownin the art. In such procedures, the surgeon is able to remotely repair abody wall tissue defect, such as a hernia, by using conventionallaparoscopic surgical techniques, including the insertion of trocarcannulas through the body wall for access to the defect site, the use ofa camera for remote visualization, and the use of specially designedlaparoscopic surgical tools and instruments to effect the repair. Tissuerepair implants have also been specially designed for such laparoscopicprocedures. The use of minimally invasive laparoscopic and endoscopicsurgical procedures has been found to have many documented patientbenefits and advantages when compared to conventional open surgicalprocedures. The benefits and advantages include minimal incisionsthrough the body wall, reduced scarring, reduced duration of theprocedure and concomitant time under anesthesia, decreased opportunityfor contamination of the surgical repair site with pathogens resultingin a lower incidence of hospital acquired infections, reduced pain,reduced length stay in the hospital, faster recovery time, and reducedoverall costs associated with the procedure.

In a conventional endoscopic or laparoscopic ventral hernia repairprocedure, the patient is anesthetized and prepared in a conventionalmanner. A Veress needle attached to a carbon dioxide gas source isinserted through the patient's body wall and the patient's abdominalcavity is insufflated sufficiently to provide an effective volumetricspace between the body wall and the underlying viscera for both viewingand performing the surgical procedure. Next, several conventional trocarand trocar cannula combinations are penetrated through the body wall andthe trocars are then withdrawn and removed from the cannulas. Thecannulas serve as access ports for the insertion and removal of surgicalinstruments and tools, laparoscopes, various medical devices, implants,etc. A flat hernia tissue repair patch, typically mesh, is rolled orfolded and inserted through the cannula and placed proximate to thehernia defect. The surgeon uses laparoscopic grasping tools to unroll orunfold the repair patch implant and place it over the hernia defect onthe peritoneum. This aspect of the procedure is critical in that theimplant needs to be substantially flat prior to fixation to the bodywall in order to provide for an acceptable repair. The surgeon thenpasses several stay sutures, which were pre-mounted to the repair patch,through the abdominal wall to secure the implant over the hernia defectprior to tacking. The securement of the stay sutures requires thatseveral open incisions be made to the exterior of the patient's bodywall about the hernia or body wall defect. The surgeon then typicallypasses the distal end of a conventional suture passer through thepartial incisions and into the patient's body cavity to retrieve thelegs of each stay suture. Two passes through each incision and throughthe body wall are required to capture both legs of a stay suture andmove them to the exterior of the body wall for securement. The legs ofeach suture are tensioned and are knotted together such that the knot iscontained within the incision. Next, the implant is affixed to theperitoneum and body wall using a conventional laparoscopic surgicaltacking instrument to complete the body wall defect repair. Theprocedure is completed by removing the cannulas and closing the trocarwounds, and, suturing or otherwise approximating the incisions for thestay sutures.

There is a continuing need in this art for novel and improved systemsand methods for performing laparoscopic hernia repair surgicalprocedures such as ventral hernia repair procedures. In particular,there is a need for devices which assist the surgeon in unrolling orunfolding a tissue repair implant and maintaining the implant in a flatconfiguration next to the peritoneum and body wall. There is also a needto reduce the number of or eliminate stay sutures required to position atissue repair implant prior to affixation to the peritoneum andabdominal wall in order to minimize trauma to the patient's body wall,and eliminate unnecessary incisions and associated complications such asinfections and scarring.

SUMMARY OF THE INVENTION

Therefore, novel devices and methods of positioning a tissue repairimplant in a laparoscopic surgical procedure are disclosed. A firstaspect of the present invention is a novel positioning system for use infacilitating a laparoscopic surgical hernia repair procedure. The systemhas a bar member having a top side, a bottom side, a center, and asuture receiving opening centrally located in the bar member. There is asurgical suture having a distal end and a proximal end, wherein theproximal end of the suture is mounted in the suture receiving opening ofthe bar member such that the suture extends out from the top side of thebar member.

Another aspect of the present invention is a surgical repair assembly.The surgical repair assembly has a surgical repair mesh having a topside and a bottom side, a center, and a major axis and a minor axis. Thesurgical repair assembly has a positioning system. The positioningsystem has a bar member having a top side, a bottom side, a center, alongitudinal axis, and a suture receiving opening centrally located inthe bar member. There is a surgical suture having a distal end and aproximal end, wherein the proximal end of the suture is mounted in thesuture receiving opening of the bar members such that the suture extendsout from the top side of the bar member. A surgical needle attached tothe distal end of the suture. The top side of the bar member engages thebottom side of the mesh such that the longitudinal axis of the barmember is substantially aligned with the major axis of the mesh, and theneedle and suture pass through the center of the mesh above the top sideof the mesh.

Yet another aspect of the present invention is a positioning system foruse in facilitating a laparoscopic surgical hernia repair procedure. Thepositioning system has a first bar member having a top side, a bottomside, a center, a longitudinal axis, a central suture opening alignedwith the center, first and second suture openings, and a first sutureslot in the bottom side. A pivot hub member extends down from the bottomside of the first bar member, said hub member having a distal end withan outwardly extending flange, a central passage in communication withthe central suture opening, and opposed lateral slots in communicationwith the central passage and the first suture slot. The positioningsystem has a second bar member pivotally mounted to the first barmember. The second bar member has a top side, a bottom side, a center, alongitudinal axis, and a slot through the bar member, said slot has afirst end in alignment with the center and adapted to receive the distalend of the pivot hub member, and a second end adapted to receive asuture. There is a surgical suture having a distal end and a proximalend, wherein the proximal end of the suture is mounted in the suturereceiving opening such that the suture extends out from the top side ofthe bar member.

Still yet a further aspect of the present invention is a surgical repairassembly. The repair assembly has a surgical repair mesh having a topside and a bottom side, a center, and a major axis and a minor axis. Thesurgical repair assembly has a positioning system. The positioningsystem has a first bar member having a top side, a bottom side, acenter, a longitudinal axis, a central suture opening aligned with thecenter, first and second suture openings, and a first suture slot in thebottom side. A pivot hub member extends down from the bottom side of thefirst bar member, said hub member having a distal end with an outwardlyextending flange, a central passage in communication with the centralsuture opening, and opposed lateral slots in communication with thecentral passage and the first suture slot. The positioning system has asecond bar member pivotally mounted to the first bar member. The secondbar member has a top side, a bottom side, a center, a longitudinal axis,and a slot through the bar member, said slot having a first end inalignment with the center and adapted to receive the distal end of thepivot hub member and a second end adapted to receive a suture. There isa surgical suture having a distal end and a proximal end, wherein theproximal end of the suture is mounted in the suture receiving openingsuch that the suture extends out from the top side of the bar member.The top side of the first bar member engages the bottom side of the meshsuch that the longitudinal axis of the top bar member is substantiallyaligned with the major axis of the mesh, and the longitudinal axes ofthe first and second bar members are substantially aligned. The suturepasses through the mesh at the central suture opening and the first andsecond suture openings such that the suture extends out from the meshabove the central opening, and a first suture segment is formed on thetop side of the mesh between the first and second suture openings, and asecond suture segment is formed in the first suture slot between thesecond suture opening and the central suture opening.

A further aspect of the present invention includes methods of repairinga tissue wall defect in a surgical procedure using the above describedpositioning systems and surgical repair assemblies

These and other aspects and advantages of the present invention willbecome more apparent from the following description and accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a hernia mesh implant of the prior artwith four stay sutures mounted to the mesh for affixation to a bodywall.

FIG. 2 is a cut-away view of an abdominal cavity showing the implant ofFIG. 1 in position to be secured to the abdominal wall against theperitoneum and over a hernia defect; a suture retriever is shownpenetrating the body wall in a position to catch a tail of a stay sutureto move it to the exterior of the body wall for knotting and securement.

FIG. 3 is a partial magnified view of the body wall of FIG. 2 showingthe implant of FIG. 1 secured to the inner side of the abdominal wall.The implant is seen to be partially secured with the stay sutures. Theknots of the sutures are seen to be contained within incisions below thesurface of the skin made for access by the suture passer instrument. Thesutures are seen to have formed loops. The implant is also seen to havebeen primarily secured with conventional surgical tacks after securementwith the stay sutures.

FIG. 4 is a perspective view of a positioning apparatus of the presentinvention having a single bar member.

FIG. 5 is a perspective view of an alternate embodiment of a positioningapparatus of the present invention having two bar members.

FIG. 6 is a perspective view illustrating the initial step in mountingthe novel positioning system of FIG. 4 to a conventional flat singlelayer mesh implant suitable for a laparoscopic ventral hernia repair;the needle tip has penetrated the center of the mesh from the bottomside.

FIG. 7 shows the positioning system fully mounted to the bottom side ofthe mesh implant with the needle and suture completely drawn through themesh and positioned above the top side of the mesh implant; the barmember is seen to be centrally located adjacent to the bottom side ofthe mesh with optional adhesive members also engaging the bottom side ofthe mesh.

FIG. 8 is a perspective view illustrating the mesh implant andpositioning system of FIG. 7, wherein the mesh implant has been rolledprior to insertion through a trocar cannula into the abdominal cavity;the attached needle and suture are seen to hang freely and the bottom ofthe mesh implant and the mounted bar can be seen.

FIG. 9 is a perspective view of the mesh and positioning system assemblyof FIG. 8 showing the top of the mesh and a section of suture extendingoutwardly from the center of the mesh.

FIG. 10 shows the mesh and positioning system assembly after insertioninto the abdominal cavity with the mesh in the rolled-up configuration.The assembly is positioned adjacent to the hernia defect with the needleand suture in position for the needle and suture to be passed throughthe hernia defect.

FIG. 11 shows the mesh and positioning system after the needle has beendriven through the hernia defect; the mesh is still in a rolled-upconfiguration.

FIG. 12 is a side sectional view showing the needle and suture pulledthrough the defect with the suture partially exiting the defect suchthat the assembly is in a position over the defect adjacent to theperitoneum.

FIG. 13 is an interior perspective view showing clocking of the barmember to orient the mesh implant to an appropriate position over thebody wall defect; the mesh is unrolled and has been placed back into asubstantially flat configuration.

FIG. 14 is a view from the interior of the patient's abdominal cavitythat shows the assembly in position over the body wall defect after theperiphery of the mesh implant has been secured with surgical tacks andprior to removal of the positioning apparatus.

FIG. 15 is a perspective view of an alternate embodiment of apositioning system having a single bar.

FIG. 16 illustrates the positioning system of FIG. 15 being mounted to asingle layer hernia mesh implant.

FIG. 17 illustrates the positioning system and mesh of FIG. 16 after theassembly has been completed. The mesh implant is drawn substantiallytransparent to illustrate the underlying positioning system.

FIG. 18 is an exploded perspective view of an alternate embodiment of adouble bar positioning system of the present invention.

FIGS. 18A and 18B are partial perspective views of the bottom of the topbar of the positioning system of FIG. 18 showing the pivot hub andsuture passing holes and a slot for receiving a suture segment.

FIG. 19 is perspective view showing the two bars assembled into apositioning system.

FIG. 20 is a magnified partial top view of the center section of theassembly of FIG. 19 showing a surgical suture mounted to the assembly.

FIG. 21 is a magnified partial bottom view of the center section of theassembly of FIG. 19 showing a surgical suture mounted to the assembly.

FIG. 22 is a perspective view of the positioning system of FIG. 19showing the rotational capacity of the bottom bar.

FIG. 23 is a perspective view showing the positioning system of FIG. 19mounted to a flat, single layer mesh implant. The mesh implant is drawnsubstantially transparent to illustrate the underlying positioningsystem.

FIG. 24 is a side partial cross-sectional view of the central section ofthe assembly of FIG. 19 with both bars in longitudinal alignment.

FIG. 25 is a perspective view of the assembly of FIG. 23 rolled inpreparation for insertion through a trocar cannula.

DETAILED DESCRIPTION OF THE INVENTION

The novel mesh positioning systems of the present invention aremanufactured from conventional biocompatible materials, includingpolypropylene, ABS, polyester, nylon, polyurethane, and the like. Thesystems may be manufactured using conventional manufacturing processesincluding injection molding, cutting, machining, extruding, forming, inkjet printing, punching, combinations thereof and the like. The surgicalsutures useful in the practice of the present invention includeconventional braided and monofilament sutures. The sutures are made fromconventional absorbable and nonabsorbable biocompatible polymericmaterials and combinations of such materials. The absorbable polymersmay include conventional absorbable polymers including syntheticpolyesters such as lactones including polylactide, polyglycolide,polydioxanone, polyglycolic acid, epsilon-caprolactone, copolymersthereof and the like. The absorbable polymers may also includeconventional natural polymers such as polypeptides, collagen, etc. Thenonabsorbable polymers may include conventional nonabsorbable polymerssuch as polypropylene, polyethylene, polyester, Nylon, etc. The surgicalneedles mounted to the surgical sutures will be made from conventionalbiocompatible materials including but not limited to surgical stainlesssteels. The optional adhesive sections used with the systems of thepresent invention may be made from conventional biocompatible adhesivepolymeric materials that provide a ready release including silicones,acrylics, polyurethanes, epoxies, cyanoacrylates, and the like.

The tissue repair implants useful with the positioning systems of thepresent invention will typically be made from conventional surgicalrepair fabrics including meshes, nonwovens, films, combinations thereof,and the like. The tissue repair implants may be made from conventionalbiocompatible materials including absorbable polymers, nonabsorbablepolymers, and combinations of absorbable and nonabsorbable polymers. Theabsorbable polymers may include conventional absorbable polymersincluding synthetic polyesters such as lactones including polylactide,polyglycolide, polydioxanone, polyglycolic acid, epsilon-caprolactone,copolymers thereof and the like. The absorbable polymers may alsoinclude conventional natural polymers such as polypeptides, collagen,etc. The nonabsorbable polymers may include conventional nonabsorbablepolymers such as polypropylene, polyethylene, polyester, expandedpolytetrafluoroethylene, Nylon, etc. The tissue repair implantspreferably have conventional anti-adhesion barriers mounted on theirvisceral sides. Examples of such anti-adhesion barriers include oxidizedregenerated cellulose, polyglecaprone 25, ptfe, polydioxanone, and thelike.

Referring initially to FIGS. 1-3, a prior art method of affixing asingle layer mesh in a laparoscopic procedure wherein stay sutures areused is illustrated. Flat mesh tissue repair implant 5 is seen to haveflat base member 10 having top side 12, bottom side 14 and periphery 18.The implant 5 is seen to have four stay sutures 30 mounted about theperiphery 18. The sutures 30 are mounted so that two legs/limbs 32 ofthe sutures 30 extend upwardly through base member 10 above top side 12.As seen in FIGS. 2 and 3, the implant 5 has been moved into abdominalcavity 40 between underlying viscera 45 and the bottom side 54 of bodywall 50. In order to position the repair implant 5 over a defect 58 inbody wall 50, the surgeon makes cuts 62 (incisions) through the outerskin layer 60 on the top side 52 of body wall 50. The distal end 82 of asuture passer 80 is passed through the body wall 50 through skin cuts 62and is used to retrieve the limbs 32 of the sutures such that a sectionof each limb 32 extends beyond the cuts 62 and outer skin layer 60. Theend 82 of suture passer 80 must be passed through the body wall 50 eachtime a single limb 32 is retrieved. For each stay suture 30, the distalend 82 of suture retriever 80 must be passed through twice at differentangles in order to retrieve both limbs 32 of suture 30 and form a sutureloop 35 having knot 38 in each suture 30. Prior to forming the sutureloop 35 the surgeon tensions the legs/limbs 32 to move the top side 12of base member 10 adjacent to the peritoneum 55 on the bottom side 54 ofbody wall 50. The legs/limbs 32 are then tied using conventionalsurgical knots 38. The knots 38 are situated in the fascia underlyingthe outer skin layer 60. This procedure is repeated for all of the staysutures 30 in order to properly position the implant 5 over the bodywall defect 58. Once positioned, the base member 10 of the implant 5 canbe affixed to the peritoneum 55 and body wall 50 using a plurality ofconventional surgical tacks 70 located about the periphery 18. Althoughthis procedure provides for satisfactory location of the implant 5 abouta defect in a body wall, there are several disadvantages attendant withits use. The disadvantages include multiple skin incisions and abdominalwall punctures necessary to retrieve the ends of the stay sutures inorder to form suture loops and knots to secure the mesh implant to theperitoneum or interior of the body wall. This may result in significanttrauma to the tissues of the abdominal wall, and may result in pain tothe patient and an extension of the post-operative healing time. Theincisions and penetrations may provide pathways for hospital acquiredinfections. The suture loops formed in the stay sutures remain in thepatient after the procedure and may produce pain during typical dailymovements by the patient, even after the healing process is complete.Other disadvantages include longer operation/procedure times associatedwith passing the suture limbs and making conventional knots on eachtransfascial suture.

Applicants' novel mesh positioning system for mesh repair implantseliminates these disadvantages since it eliminates the need forconventional stay (transfascial) sutures. As seen in FIGS. 4 and 5, twoembodiments of a novel mesh positioning system of the present inventionare illustrated. Referring first to FIG. 4, the mesh positioning system100 is seen to have a bar member 110. Bar member 110 is seen to haveopposed rounded ends 112. Bar member 110 has top side 114 and bottomside 116, and opposed lateral sides 118. The bar member 110 haslongitudinal axis 120 and center 125. The proximal end 132 of suture 130is seen to extend from top side 114 of bar member 110 at center 125. Theproximal end 132 of suture 130 may be attached to bar member 110 in aconventional manner including gluing, knotting, welding, mechanicalfasteners, etc. The distal end 134 of suture 130 is mounted to theproximal end 142 of surgical needle 140 having distal piercing point144. Surgical needle 140 preferably has a straight configuration, butmay have other configurations including curved. Adhesive sections 150are seen on top side 114 on either end of bar member 110. The adhesivesections 150 may consist of coatings, tapes, patches, etc. Analternative embodiment of a mesh positioning system 160 of the presentinvention is seen in FIG. 5. Positioning system 160 is seen to have topbar member 110 pivotally mounted in a conventional manner to bottom barmember 170 such that bar member 110 and bar member 170 may be rotatedwith respect to each other. Bar member 170 is seen to have opposedrounded ends 172. Bar member 170 has top side 174 and bottom side 176,and opposed lateral sides 178. The bar member 110 has longitudinal axis180 and center 185. The bar members 110 and 170 are pivotally connectedat their centers 125 and 185, respectively. Surgical suture 130 withattached surgical needle 140 is seen to be affixed to and extend frombar member 130 in a similar manner as that described above.

A method of affixing a mesh tissue repair implant over a defect in abody wall using the novel mesh positioning system 100 of the presentinvention is illustrated in FIGS. 6-14. Referring first to FIG. 6, amesh positioning system 100 of the present invention is seen adjacent toa surgical mesh implant 200. Surgical mesh implant 200 is seen to havebottom side 204, top side 202, and center 205. The implant 200 hasopposed lateral sides 210 connected by opposed end sides 212. The meshimplant 200 will typically have a flat configuration. The mesh implant200 is seen to have location marker 220 having longitudinal marker 224and latitudinal marker 222. The location marker 220 is centered on themesh implant 200 such that longitudinal marker 224 and latitudinalmarker 222 intersect at mesh implant center 205. The bar member 110 ismounted to the bottom 204 of mesh implant 200 by aligning thelongitudinal axis 120 of bar member 110 with the longitudinal marker224, and by aligning the center 125 of longitudinal member 110 with thecenter 205 of mesh implant 200. The distal end 144 of surgical needle140 is moved or pushed through the center 125 of mesh implant 200 alsomoving the suture 130 through the mesh implant 200 and causing the barmember 110 to be moved proximate the bottom side 204 of mesh implant200. Then, the top side 114 of bar member 110 is pushed against thebottom side 204 of mesh member 200 such that adhesive sections 150releasably engage sections of bottom side 204 to form the assembly 240.The resulting assembly 240 is now ready for use in a laparoscopic bodywall defect surgical procedure, such as a hernia repair procedure. Inorder to insert the assembly through a conventional trocar cannula, itis necessary for the assembly 240 to be rolled up. A preferred way toroll the assembly 240 is seen in FIGS. 8 and 9. The assembly 240 isplaced by the surgeon on a flat surface such that the top surface 202 ofmesh 200 is adjacent to the flat surface. Then, the mesh 200 is rolledabout bar member 110 by grasping both lateral sides 210 and rolling thesides inwardly to form rolls or rolled sections 215 adjacent to lateralsides 118 of bar member 110.

As seen in FIGS. 10-14, the surgeon inserts the rolled assembly 240 intoa patient's abdominal cavity 250. Abdominal cavity 250 is seen to besurrounded by abdominal wall 260 having inner peritoneal layer 270 andouter epidermal layer 265. A body wall defect 280 is seen to protrudeinto body wall 260 along with a section of peritoneum 270 creatinghernia sack 275. The body wall defect 280 has outer periphery 282. Thesurgeon then locates the center 285 of the defect 280 and pushes theneedle 140 and suture 130 through the defect 280, through the herniasack 275, and though body wall 260 such that the needle 140 exits theepidermal layer 265 of the body wall 260 along with a section of suture130 and the top side 202 of the mesh 200 is positioned next to theperitoneum 270. The surgeon positions assembly 240 such that the mesh200 is properly aligned with the defect 280 about the defect center 285.The surgeon then pulls on the needle 140 and attached suture 130 toassure that the top side 202 of mesh implant 200 is in apposition to thebody wall 260 and peritoneal layer 270. The suture 130 is then clampedadjacent to epidermal layer 265 using a surgical device such as aconventional hemostat 290 or other appropriate surgical instrument ordevice. The rolled mesh 200 and attached bar member 110 are clocked orrotated into the appropriate orientation to cover the hernia defect 280.The surgeon then unrolls the rolled sections 215 such that the topsurface 202 of the mesh 200 is in contact with peritoneum 270 and themesh implant 200 extends sufficiently beyond the periphery 282 of herniadefect 280 to provide a margin for affixation, preferably with surgicaltacks. Next, as seen in FIG. 13 the unrolled mesh 200 is affixed aboutits periphery with conventional surgical tacks 295. After successfulplacement and fixation of the mesh 200 the bar member 110 and theremaining segment of suture 130 are pulled backward away from the bodywall 260 and removed from the abdominal cavity 250.

An alternative embodiment of a mesh positioning system 300 having a barmember 301, surgical suture 340, and surgical needle 350 useful in thepractice of the present invention is illustrated in FIGS. 15-17. The barmember 301 is seen to have opposed rounded ends 302. Bar member 301 hastop side 304 and bottom side 306, and opposed lateral sides 308. The barmember 301 has longitudinal axis 320 and center 325. The center hole 310extends through bar member 301 at center 325. Suture attachment hole 312and suture passing hole 314 are located adjacent to and on either sideof center hole 310; holes 312 and 314 pass through bar member 301. Theproximal end 342 of surgical suture 340 is attached to bar member 301 insuture attachment hole 312 and is seen to extend from suture attachmenthole 312 from top side 304 of bar member 301. The distal end 344 ofsuture 340 is mounted to the proximal end 352 of straight surgicalneedle 350 having distal piercing point 354. The positioning system 300is mounted to surgical repair mesh 360 to form assembly 390. The mesh360 is seen to have top side 362 and bottom side 364. The mesh 360 hascenter 372, major axis 374 and minor axis 376. Mesh 360 has outerperiphery 368. In order to mount positioning system 300 to mesh 360 toform assembly 390, the longitudinal axis 325 of bar member 301 isaligned with major axis 374 of mesh 360. The top side 304 of bar member301 is placed adjacent to bottom side 364 of mesh 360 such that thecenters 325 and 372 are in substantial alignment. Next, the piercingpoint 354 of needle 350 is pushed through mesh 360 from the bottom side364 at a location adjacent to center 372, and the suture 340 is pulledthrough. The needle 350 is then passed down from top side 362 throughmesh 360 and through opening 314 in bar member 301 forming top suturesegment 346. The needle 350 is then passed from the bottom side 306 ofbar member 301 through center opening 310 and through mesh 360 alongwith the remaining suture 340. Suture segment 348 is formed on bottomside 306. This completes the assembly of the assembly 390. The assembly390 is used in a manner similar to assembly 240 as described above.

An alternative embodiment of a double bar mesh positioning system 400 ofthe present invention is seen in FIGS. 18-25. The positioning system 400is seen to have top bar member 410 and bottom bar member 450. Top barmember 410 is seen to have top side 412, bottom side 414, and opposedends 416 connecting opposed lateral sides 418. The bar member 410 haslongitudinal axis 420 and center 425. Suture passing holes 427 and 429extend through bar member 410. Extending downwardly from the bottom side414 of bar member 410 and coextensive with center 425 is the pivot hubmember 430. Hub member 430 is seen to have a generally cylindricalconfiguration with lateral side slots 434 in communication with centralpassage 431. Flange member 436 is seen to extend about the bottom end432 of hub member 430. Passage 438 is seen to extend up through barmember 410 and to be in communication with central suture passing hole428. Contained in the bottom 414 of bar member 410 is the suturereceiving slot 440. Slot 440 has bottom 441, channel 442, first end 443in communication with lateral slot 434 of hub member 430 and second end444 in communication with suture passing hole 429. Bottom bar member 450is seen to have top side 452, bottom side 454, and opposed ends 456connecting opposed lateral sides 458. The bar member 450 haslongitudinal axis 460 and center 465. Pivot hub receiving hole 470 isseen to extend through bar member 450 and is located at the center 465.The bar member 450 is also seen to have suture passage slot 480extending through bar member 450. The slot 480 has channel 481, firstend 482 in communication with pivot hub receiving hole 470 and secondrounded end 484 in communication with suture opening 429. The barmembers 410 and 450 are pivotally mounted to each other by forcing theend of hub member 460 into hub receiving hole 470 such that the flangemember 436 is engaged on or below the bottom side 454 of bar member 450.A surgical suture 500 having a proximal end 502 and a distal end 504 ismounted to opening 427 such that the suture extends from opening 427above top side 412 of bar member 440. This may be accomplished bymounting a plug like member 510 to proximal end 502 or by knotting theend 502. The proximal suture end 502 can also be glued or cemented intoopening 427. The distal end 504 of suture 500 is mounted to the proximalend 532 of surgical needle 530 having distal end 534 and distal piercingdistal tip 536.

The system 400 is mounted to a surgical repair mesh 550 to form a repairassembly 600 in the following manner. The bar members 410 and 450 aremanipulated such that the longitudinal axes 420 and 460 are inalignment. Next the center 425 of bar member 410 is aligned with thecenter 560 of mesh 550. The surgical needle 530 attached to suture 500is then pushed through mesh 550 from bottom side 552 through top side554. The needle 530 is then pushed through the top side 554 of mesh 550through underlying suture passing hole 429 and through opening 484 inbar members 410 and 450, respectively, and a length of free suture 500is also moved through forming top suture segment 520. Next the needle530 is moved through pivot hole 470 and out through central passage 431and central suture passing hole 428. As the suture 500 is withdrawn, asection of the suture 500 will pass through slot 434 and channel 481 inslot 480, and as the suture 500 is further withdrawn and tightenedsuture segment 525 will move into channel 442 of slot 440. The top side414 of bar member 410 will now be engaged with the bottom side 552 ofmesh 550. The mesh may be rolled about the positioning system 400 toform rolls 565 to facilitated passage through a cannula into theabdominal cavity. If desired, the rolls 565 may be optionally securedwith sutures 570, which are then removed prior to unrolling the mesh 550after movement through a cannula. The repair assembly 600 is used in amanner similar to that described above for assembly 400, except that thebars 410 and 450 may be pivoted or rotated, sometimes described as“clocked”, with respect to each other to further support the mesh 550and aid in placement over to the body wall defect next to theperitoneum. Optionally, as partially shown in FIG. 25, the bar membersmay be provided with measurement scale markings to indicate the lengthsof the bars and the lengths of the attached meshes. Alternateconventional ways of pivotally mounting the bar members 410 and 450together may be utilized including bolts, axles, pins, rivets, etc.

Although it is preferred that the surgical sutures useful with thepositioning systems and repair assemblies of the present invention havesurgical needles mounted to an end, it will be appreciated that surgicalsutures may be utilized without mounted surgical needles. In such aconfiguration, the suture would be passed through tissue and/or theimplant using conventional surgical instruments such as conventionalsuture passing instruments. Also, if desired although not preferred,multiple sutures may be used with the positioning systems of the presentinvention.

The following example is illustrative of the principles and practice ofthe present invention, although not limited thereto.

Example 1

A patient presenting with a ventral hernia is prepared for alaparoscopic surgical hernia repair procedure in a conventional manner.After conventional preparation and administration of conventionalanesthesia, the surgeon insufflates the patient's abdominal cavity usinga conventional Veress needle attached to a medical grade carbon dioxidegas source. After insufflation, the surgeon inserts several trocarcannulas through the abdominal wall using conventional trocars. Thetrocar cannulas provide access to the abdominal cavity and access to thesurgical site. A conventional laparoscope is inserted into one of thecannulas and connected to a camera to provide the surgeon with remotevisualization. The surgeon views the hernia defect in the patient'sabdominal wall and measures the defect with a surgical ruler. Thesurgeon then selects an appropriately sized surgical hernia defectrepair mesh implant. The surgeon is provided with a mesh positioningsystem of the present invention having a single bar member. Afterdetermining the center of the mesh implant, the surgeon pushes thesurgical needle and suture of the positioning system through the bottomside of the mesh implant at the center and pulls the needle and sutureuntil the top surface of the bar member is next to and in contact withthe bottom side of the mesh implant. The surgeon then aligns the barmember with the longitudinal axis of the mesh implant and applies forceto the top side of the mesh over the optional adhesive sections on thetop side of the bar member to secure the mesh to the positioning system.The surgeon then rolls the sides of the mesh about the centrally locatedbar member in order to move the positioning system and mesh assemblythrough a conventional trocar cannula into the patient's abdominalcavity. The mesh of the assembly is unrolled using conventionallaparoscopic grasping tools. The assembly is then moved toward thedefect and the mesh is placed in apposition to the peritoneum adjacentto the hernia defect. The surgeon then grasps the surgical needle with alaparoscopic needle grasper instrument and pushes the needle and asection of the suture through the hernia defect and the hernia sack andbody wall tissue layers over the defect. The needle is then graspedexterior to the body wall and tensioned such that the top side of themesh is moved against the interior of the abdominal wall (i.e., theperitoneum) and the edges of the defect are overlapped by the mesh inthe surrounding peritoneum. The tensioned suture is maintained inposition by applying a surgical hemostat to the protruding suture, andthe needle is cut away from the suture. The surgeon then views theposition of the mesh implant over the body wall tissue defect and makespositional changes as required. The mesh is observed to be maintained ina flat configuration against the peritoneum with substantially nowrinkles. The surgeon then inserts the distal end of a conventionalsurgical tacking instrument into the patient's abdominal cavity andproceeds to tack the mesh implant about its entire periphery with acontinuous line of spaced apart tacks. The surgeon then removes the meshpositioning system from the bottom of the mesh implant by disengagingthe hemostat from the exterior section of suture and pulling the barmember away from the implant thereby pulling the remaining suturesegment back into the abdominal cavity. The positioning system is thenremoved through a cannula. Then, the instruments, cannulas and Veressneedle are removed from the patient. The trocar incisions for thecannulas are then taped with conventional surgical tape and the repairprocedure is complete. Alternatively, if there is no surgical needleattached to the suture of the positioning system, a conventional suturepasser can be used by the surgeon to pull the suture through theabdominal wall and position the mesh on the interior of the body wall.Prior to affixing the mesh implant to the body wall over the defect, thesurgeon may decide to optionally remove all or part of the hernia sack.In addition, the surgeon may decide to suture the tissue surrounding thehernia defect together prior to affixing the mesh implant.

Although this invention has been shown and described with respect todetailed embodiments thereof, it will be understood by those skilled inthe art that various changes in form and detail thereof may be madewithout departing from the spirit and scope of the claimed invention.

We claim:
 1. A positioning system for use in facilitating a laparoscopichernia repair procedure, comprising: a bar member having a top side, abottom side, a center, and a suture receiving opening centrally locatedin the bar member; a surgical suture having a distal end and a proximalend, wherein the proximal end of the suture is mounted in the suturereceiving opening such that the suture extends out from the top side ofthe bar member.
 2. The system of claim 1, additionally comprising atleast one adhesive section on the top side of the bar member forengaging a surgical mesh implant.
 3. The system of claim 1, wherein thesuture receiving opening is a bore hole.
 4. The system of claim 1wherein the suture receiving opening extends from the bottom side of thebar to the top side of the bar.
 5. The system of claim 1, additionallycomprising a surgical needle mounted to the distal end of the suture. 6.A surgical repair assembly, comprising: a surgical repair mesh having atop side and a bottom side, a center, and a major axis and a minor axis;a positioning system, comprising: a bar member having a top side, abottom side, a center, a longitudinal axis, and a suture receivingopening centrally located in the bar member; a surgical suture having adistal end and a proximal end, wherein the proximal end of the suture ismounted in the suture receiving opening such that the suture extends outfrom the top side of the bar member; and, a surgical needle attached tothe distal end of the suture, wherein the top side of the bar memberengages the bottom side of the mesh such that the longitudinal axis ofthe bar member is substantially aligned with the major axis of the mesh,and the needle and suture pass through the center of the mesh above thetop side of the mesh.
 7. A positioning system for use in facilitating alaparoscopic hernia repair procedure, comprising: a first bar memberhaving a top side, a bottom side, a center, a longitudinal axis, acentral suture opening aligned with the center, first and second sutureopenings, and a first suture slot in the bottom side; a pivot hub memberextending down from the bottom side of the first bar member, said hubmember having a distal end with an outwardly extending flange, a centralpassage in communication with the central suture opening, and opposedlateral slots in communication with the central passage and the firstsuture slot; a second bar member pivotally mounted to the first barmember, said second bar member having a top side, a bottom side, acenter, a longitudinal axis, and a slot through the bar member, saidslot having a first end in alignment with the center and adapted toreceive the distal end of the pivot hub member and a second end adaptedto receive a suture; and, a surgical suture having a distal end and aproximal end, wherein the proximal end of the suture is mounted in thesuture receiving opening such that the suture extends out from the topside of the bar member.
 8. The system of claim 7, additionallycomprising a surgical needle mounted to the distal end of the suture. 9.The system of claim 7, additionally comprising at least one adhesivesection on the top side of the bar member for engaging a surgical meshimplant.
 10. A surgical repair assembly, comprising: a surgical repairmesh having a top side and a bottom side, a center, and a major axis anda minor axis; a positioning system, comprising: a first bar memberhaving a top side, a bottom side, a center, a longitudinal axis, acentral suture opening aligned with the center, first and second sutureopenings, and a first suture slot in the bottom side; a pivot hub memberextending down from the bottom side of the first bar member, said hubmember having a distal end with an outwardly extending flange, a centralpassage in communication with the central suture opening, and opposedlateral slats in communication with the central passage and the firstsuture slot; a second bar member pivotally mounted to the first barmember, said second bar member having a top side, a bottom side, acenter, a longitudinal axis, and a slot through the bar member, saidslot having a first end in alignment with the center and adapted toreceive the distal end of the pivot hub member and a second end adaptedto receive a suture; and, a surgical suture having a distal end and aproximal end, wherein the proximal end of the suture is mounted in thesuture receiving opening such that the suture extends out from the topside of the bar member, wherein the top side of the first bar memberengages the bottom side of the mesh such that the longitudinal axis ofthe bar member is substantially aligned with the major axis of the mesh,and the longitudinal axes of the first and second bar members aresubstantially aligned, and the needle and suture pass through the meshat the central suture opening and the first and second suture openingssuch that the suture extends out from the mesh above the centralopening, and a first suture segment is formed on the top side of themesh between the first and second suture openings, and a second suturesegment is formed in the first suture slot between the second sutureopening and the central suture opening.
 11. The system of claim 10,additionally comprising a surgical needle mounted to the distal end ofthe suture.
 12. A method of performing a laparoscopic body wall defectrepair procedure, comprising the steps of: inserting the surgical repairassembly of claim 6 into a body cavity of a patient; positioning theassembly adjacent to a body wall defect such that the top side of themesh is adjacent to the defect; driving the suture through the defectand overlying body wall such that the a section of suture exits the bodywall and body cavity; tensioning the suture such that the top side ofthe mesh is placed in contact with the body wall surrounding the defect;and, securing the mesh over the defect.
 13. The method of claim 12,wherein the suture comprises a surgical needle mounted to the distalend.
 14. The method of claim 12, wherein the body wall defect is ahernia.
 15. The method of claim 12, wherein the mesh is secured withsurgical tacks.
 16. A method of performing a laparoscopic body walldefect repair procedure, comprising the steps of: inserting the surgicalrepair assembly of claim 10 into a body cavity of a patient; positioningthe assembly adjacent to a body wall defect such that the top side ofthe mesh is adjacent to the defect; driving the suture through thedefect and overlying body wall such that a section of suture exits thebody wall and body cavity; tensioning the suture such that the top sideof the mesh is placed in contact with the body wall surrounding thedefect; and, securing the mesh over the defect.
 17. The method of claim16, wherein the suture comprises a surgical needle mounted to the distalend.
 18. The method of claim 16, wherein the body wall defect is ahernia.
 19. The method of claim 16, wherein the first and second barmembers are rotated with respect to each other prior to positioning theassembly adjacent to the body wall defect.
 20. The method of claim 16,wherein the mesh is secured with surgical tacks.